CTIX News 08/11/2014 06:33:07 $CTIX
Moving forward on all fronts continuously, can't complain about that! Good work by Leo and team! Nice PR this morning
Great news that B-OM is moving forward with IND! Also, glad to see Leo address the approval of oritavancin.
Excellent PR!
Post edited to avoid duplication and to highlight what I consider a key point.
Mr. Ehrlich added, “On a broader perspective, the question has been posed to me about what last week’s FDA approval of The Medicines Company’s oritavancin, a one-time treatment for ABSSSI, means to Brilacidin. First, we congratulate The Medicines Company on their approval. Candidly, we do not view oritavancin as a potential competitor to our Brilacidin because of several key differentiators, namely pharmacokinetic profiles and subsequent implications. Ortavancin is a lipoglycopeptide, the same class of drug as Durata Pharmaceutical’s Dalvance®
(Dalbavancin), and both drugs have a very long half-life of approximately one to two weeks. This means that the drug remains in a patient’s system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance. Brilacidin, a new class of drug, has a half-life of only 13 to 16 hours, a time frame that we believe is ideal for a one-time treatment, while greatly decreasing the chance of resistance developing. Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance. Overall, in addition to the direct comparison with ABSSSI, we look at our asset as offering much more potential as an antibiotic, especially with room temperature formulations paving the way for possibly treating a wide range of other indications, such as diabetic foot ulcer infections, ophthalmic infections and otitis media. ABSSSI alone is more than a billion-dollar market and growing, and there is room for everyone with the best drug taking the lion’s share of dollar sales. So while we applaud a new therapeutic option for patients, we are not concerned about the approval of ortavancin.”
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol has recently completed a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
- See more at: http://cellceutix.com/cellceutix-prepares-for...kETMh.dpuf
And there it is
Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis
Cellceutix Corporation (OTCQB: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that the Company has just received the final toxicology report for Brilacidin-OM. Cellceutix is developing Brilacidin-OM as a new treatment for oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy.
Cellceutix is reviewing the report, which will be added to finalize the already prepared Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration seeking approval to commence a Phase 2 clinical trial of Brilacidin-OM as soon as possible.
“The past week was full of great news for us; that enrollment for the Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections will be completed this month, the statistical data on our anti-psoriasis drug Prurisol showed that it attained it's primary endpoint in a Phase 1 trial, and now the data to complete the IND for Brilacidin-OM. We look forward to the IND submission in a bid to fill an area of great unmet medical need to the nearly half a million patients that suffer the painful effects of oral mucositis every year,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix.
Mr. Ehrlich added, “On a broader perspective, the question has been posed to me about what last week’s FDA approval of The Medicines Company’s oritavancin, a one-time treatment for ABSSSI, means to Brilacidin. First, we congratulate The Medicines Company on their approval. Candidly, we do not view oritavancin as a potential competitor to our Brilacidin because of several key differentiators, namely pharmacokinetic profiles and subsequent implications. Ortavancin is a lipoglycopeptide, the same class of drug as Durata Pharmaceutical’s Dalvance®
(Dalbavancin), and both drugs have a very long half-life of approximately one to two weeks. This means that the drug remains in a patient’s system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance. Brilacidin, a new class of drug, has a half-life of only 13 to 16 hours, a time frame that we believe is ideal for a one-time treatment, while greatly decreasing the chance of resistance developing. Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance. Overall, in addition to the direct comparison with ABSSSI, we look at our asset as offering much more potential as an antibiotic, especially with room temperature formulations paving the way for possibly treating a wide range of other indications, such as diabetic foot ulcer infections, ophthalmic infections and otitis media. ABSSSI alone is more than a billion-dollar market and growing, and there is room for everyone with the best drug taking the lion’s share of dollar sales. So while we applaud a new therapeutic option for patients, we are not concerned about the approval of ortavancin.”
About Cellceutix:
Thanks for the post and please add to the discussion whenever you can. I am also of the opinion that at 215mg/m2 we are nearing the equivalent levels of the mouse studies. But in the absence of something more definitive, it is still an opinion. I would like to see at least one more cohort in the range of 300mg/m2, or 30x the level of cohort 1.
Another thing we don't know the answer to yet is how frequently K can be administered. This adds another dimension to the issue. Could delivery of K be increased with higher frequency treatments?
Good chance we have 100% enrollment on B. Otherwise, maybe a B-OM IND, or K cohort advancement news?
Should we expect any news / PR today given Thursdays update by Leo? ...anything due ?.thanks
Hoping this is clear,... but then you probably knew all this!
From poster: biodoc
" I'm a long term holder and extremely bullish on CTIX. I read the board daily but have never posted. The dosing discussion is interesting. Here's how I read it:
Cohort 8 dose is 215 mg/m2 (intravenous)
Mouse dose dramatically slowing tumor growth was 200 mg/kg (intraperitoneal)
Human Equivalent Dose in mg/kg= Animal dose (mg/kg) * Animal Km/ Human Km
HED Kevetrin= 200mg/kg * 3/37
= 17.43 mg/kg
Conversion of Cohort 8 dose from mg/m2 to mg/kg:
Cohort 8 Kevetrin= 215 mg/m2/37 = 5.81 mg/kg
So Cohort 8 Intravenous dose is 5.81 mg/kg. This dose is exactly 1/3 the INTRAPERITONEAL dose of 17.43 mg/kg used in the mouse study. Intraperitoneal dosing will result in lower serum levels than intravenous dosing when comparing the same dose. I do not know the correlation coefficient for Kevetrin IP/IV but it seems to me (if I understand this correctly) that Cohort 8 serum levels are likely in the same ballpark as serum levels obtained with 200mg intraperitoneal mouse dosing."
Thanks for that!!
Good Morning, CTIX!
Great post thank you for sharing.
Have a great week everyone!
Oh yes it it! Flying in and out of there all the time. I'll take us to the party lol!
Calculations based on formulas in article cited earlier:
http://www.fasebj.org/content/22/3/659.full
I just plugged in numbers.
No doubt, intraperitoneal dosing likely has some very real advantages over IV administration, especially for intraabdominal tumors. Advantages include slower absorption and higher intraperitoneal drug levels. To achieve therapeutic serum levels to treat most tumors, I think modifying the intravenous protocol would be more controllable and preferable to intraperitoneal injection.
ROMAD Diver - You made me "snort" with laughter while eating a brownie, damned near choked but it was worth it!
I just found out from a secret source that found out in a meeting of secret people talking about secret stuff that they discovered Dr. Menon's secret ingredient used in Kevetrin. It ends up the secret ingredient is Chuck Norris DNA! Expect the news to come out sometime this week, and the share price to be somewhere in the $2,000,000,000 per share range.
DISCLAIMER! In order to relieve some of the tension on this board, this was meant as a joke. Do not trade based on this information--Chuck Norris DNA is unharvestable.
Thanks for the links KMBJN - it would appear from the abstracts they don't think BSA is the end all either and feel "alternatives based on fundamental principles of clinical pharmacology" are more appropriate. Lots of variables....... With regards to the vancomycin use, my daughter confirmed they use it a lot for back surgeries but not brain since there are concerns about ototoxicity. A study I read about vancomycin powder concluded "it doesn't cut infection post spine surgery as noted here:
http://www.empr.com/vancomycin-powder-doesnt-...le/324883/
But who am I to say....... maybe it makes the docs feel better that they are being "thorough".......
Do you have a source for that?
I found one thing ( http://www.medscape.com/viewarticle/780560) that seemed to indicate IP was superior to IV. I'm not exactly an expert so I don't know how this, if at all, would translate to our case.
Thanks for the insight that takes mouse dose administration verses human IV into account.
Hi biodoc, excellent observation! Never considered the serum level differences between intraperitoneal vs intravenous. Great first post, stop in more often.
I'll access the article below from my office tomorrow and see what McGonicle and Ruggeri (2014) have to say, but seems they advocate hierarchical data sets that may include Bayesian inference (Multi Treatment Comparisons) and Markov chain Monte Carlo. If anyone can access this, please feel free to do so and report.
Animal models of human disease: Challenges in enabling translation
http://www.sciencedirect.com/science/article/...5213004929
Looks like Dr. Menon's team is not using simple arithmetic modeling involved in Baur conversions except as a guide for starting dose, as noted by you and others.
Moving forward on all fronts continuously, can't complain about that! Good work by Leo and team! Nice PR this morning
Great news that B-OM is moving forward with IND! Also, glad to see Leo address the approval of oritavancin.
Excellent PR!
Post edited to avoid duplication and to highlight what I consider a key point.
Mr. Ehrlich added, “On a broader perspective, the question has been posed to me about what last week’s FDA approval of The Medicines Company’s oritavancin, a one-time treatment for ABSSSI, means to Brilacidin. First, we congratulate The Medicines Company on their approval. Candidly, we do not view oritavancin as a potential competitor to our Brilacidin because of several key differentiators, namely pharmacokinetic profiles and subsequent implications. Ortavancin is a lipoglycopeptide, the same class of drug as Durata Pharmaceutical’s Dalvance®
(Dalbavancin), and both drugs have a very long half-life of approximately one to two weeks. This means that the drug remains in a patient’s system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance. Brilacidin, a new class of drug, has a half-life of only 13 to 16 hours, a time frame that we believe is ideal for a one-time treatment, while greatly decreasing the chance of resistance developing. Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance. Overall, in addition to the direct comparison with ABSSSI, we look at our asset as offering much more potential as an antibiotic, especially with room temperature formulations paving the way for possibly treating a wide range of other indications, such as diabetic foot ulcer infections, ophthalmic infections and otitis media. ABSSSI alone is more than a billion-dollar market and growing, and there is room for everyone with the best drug taking the lion’s share of dollar sales. So while we applaud a new therapeutic option for patients, we are not concerned about the approval of ortavancin.”
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol has recently completed a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
- See more at: http://cellceutix.com/cellceutix-prepares-for...kETMh.dpuf
And there it is
Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis
Cellceutix Corporation (OTCQB: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that the Company has just received the final toxicology report for Brilacidin-OM. Cellceutix is developing Brilacidin-OM as a new treatment for oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy. Cellceutix is reviewing the report, which will be added to finalize the already prepared Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration seeking approval to commence a Phase 2 clinical trial of Brilacidin-OM as soon as possible.
“The past week was full of great news for us; that enrollment for the Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections will be completed this month, the statistical data on our anti-psoriasis drug Prurisol showed that it attained it's primary endpoint in a Phase 1 trial, and now the data to complete the IND for Brilacidin-OM. We look forward to the IND submission in a bid to fill an area of great unmet medical need to the nearly half a million patients that suffer the painful effects of oral mucositis every year,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix.
Mr. Ehrlich added, “On a broader perspective, the question has been posed to me about what last week’s FDA approval of The Medicines Company’s oritavancin, a one-time treatment for ABSSSI, means to Brilacidin. First, we congratulate The Medicines Company on their approval. Candidly, we do not view oritavancin as a potential competitor to our Brilacidin because of several key differentiators, namely pharmacokinetic profiles and subsequent implications. Ortavancin is a lipoglycopeptide, the same class of drug as Durata Pharmaceutical’s Dalvance®
(Dalbavancin), and both drugs have a very long half-life of approximately one to two weeks. This means that the drug remains in a patient’s system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance. Brilacidin, a new class of drug, has a half-life of only 13 to 16 hours, a time frame that we believe is ideal for a one-time treatment, while greatly decreasing the chance of resistance developing. Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance. Overall, in addition to the direct comparison with ABSSSI, we look at our asset as offering much more potential as an antibiotic, especially with room temperature formulations paving the way for possibly treating a wide range of other indications, such as diabetic foot ulcer infections, ophthalmic infections and otitis media. ABSSSI alone is more than a billion-dollar market and growing, and there is room for everyone with the best drug taking the lion’s share of dollar sales. So while we applaud a new therapeutic option for patients, we are not concerned about the approval of ortavancin.”
About Cellceutix:
Thanks for the post and please add to the discussion whenever you can. I am also of the opinion that at 215mg/m2 we are nearing the equivalent levels of the mouse studies. But in the absence of something more definitive, it is still an opinion. I would like to see at least one more cohort in the range of 300mg/m2, or 30x the level of cohort 1.
Another thing we don't know the answer to yet is how frequently K can be administered. This adds another dimension to the issue. Could delivery of K be increased with higher frequency treatments?
Good chance we have 100% enrollment on B. Otherwise, maybe a B-OM IND, or K cohort advancement news?
Should we expect any news / PR today given Thursdays update by Leo? ...anything due ?.thanks
Hoping this is clear,... but then you probably knew all this!
From poster: biodoc
" I'm a long term holder and extremely bullish on CTIX. I read the board daily but have never posted. The dosing discussion is interesting. Here's how I read it:
Cohort 8 dose is 215 mg/m2 (intravenous)
Mouse dose dramatically slowing tumor growth was 200 mg/kg (intraperitoneal)
Human Equivalent Dose in mg/kg= Animal dose (mg/kg) * Animal Km/ Human Km
HED Kevetrin= 200mg/kg * 3/37
= 17.43 mg/kg
Conversion of Cohort 8 dose from mg/m2 to mg/kg:
Cohort 8 Kevetrin= 215 mg/m2/37 = 5.81 mg/kg
So Cohort 8 Intravenous dose is 5.81 mg/kg. This dose is exactly 1/3 the INTRAPERITONEAL dose of 17.43 mg/kg used in the mouse study. Intraperitoneal dosing will result in lower serum levels than intravenous dosing when comparing the same dose. I do not know the correlation coefficient for Kevetrin IP/IV but it seems to me (if I understand this correctly) that Cohort 8 serum levels are likely in the same ballpark as serum levels obtained with 200mg intraperitoneal mouse dosing."
Thanks for that!!
Good Morning, CTIX!
Great post thank you for sharing.
Have a great week everyone!
Oh yes it it! Flying in and out of there all the time. I'll take us to the party lol!
Calculations based on formulas in article cited earlier:
http://www.fasebj.org/content/22/3/659.full
I just plugged in numbers.
No doubt, intraperitoneal dosing likely has some very real advantages over IV administration, especially for intraabdominal tumors. Advantages include slower absorption and higher intraperitoneal drug levels. To achieve therapeutic serum levels to treat most tumors, I think modifying the intravenous protocol would be more controllable and preferable to intraperitoneal injection.
ROMAD Diver - You made me "snort" with laughter while eating a brownie, damned near choked but it was worth it!
I just found out from a secret source that found out in a meeting of secret people talking about secret stuff that they discovered Dr. Menon's secret ingredient used in Kevetrin. It ends up the secret ingredient is Chuck Norris DNA! Expect the news to come out sometime this week, and the share price to be somewhere in the $2,000,000,000 per share range.
DISCLAIMER! In order to relieve some of the tension on this board, this was meant as a joke. Do not trade based on this information--Chuck Norris DNA is unharvestable.
Thanks for the links KMBJN - it would appear from the abstracts they don't think BSA is the end all either and feel "alternatives based on fundamental principles of clinical pharmacology" are more appropriate. Lots of variables....... With regards to the vancomycin use, my daughter confirmed they use it a lot for back surgeries but not brain since there are concerns about ototoxicity. A study I read about vancomycin powder concluded "it doesn't cut infection post spine surgery as noted here:
http://www.empr.com/vancomycin-powder-doesnt-...le/324883/
But who am I to say....... maybe it makes the docs feel better that they are being "thorough".......
Do you have a source for that?
I found one thing ( http://www.medscape.com/viewarticle/780560) that seemed to indicate IP was superior to IV. I'm not exactly an expert so I don't know how this, if at all, would translate to our case.
Thanks for the insight that takes mouse dose administration verses human IV into account.
Hi biodoc, excellent observation! Never considered the serum level differences between intraperitoneal vs intravenous. Great first post, stop in more often.
I'll access the article below from my office tomorrow and see what McGonicle and Ruggeri (2014) have to say, but seems they advocate hierarchical data sets that may include Bayesian inference (Multi Treatment Comparisons) and Markov chain Monte Carlo. If anyone can access this, please feel free to do so and report.
Animal models of human disease: Challenges in enabling translation
http://www.sciencedirect.com/science/article/...5213004929
Looks like Dr. Menon's team is not using simple arithmetic modeling involved in Baur conversions except as a guide for starting dose, as noted by you and others.
